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Research question

Dexamethasone (DMS) 0.1% is the standard of care after Descemet membrane endothelial keratoplasty (DMEK) in the Netherlands. It effectively prevents rejection but causes intra ocular pressure (IOP) elevation in one of four patients. Recent studies suggest Fluorometholone (FML) 0.1% effectively prevents rejection with minimal impact on IOP, but there is no RCT comparing both drugs. Moreover, it remains unknown if steroids may be stopped after one year as there is no RCT to support decision making.

 

Hypothesis

FML 0.1% in the first year and discontinuing steroids in the second year is a cost-effective strategy after DMEK.

 

Design

Multicenter RCT.

 

Population

Adults undergoing DMEK.

 

Intervention

STEP-I (Year 1):

Control: DMS 0.1% 6 times a day for 1 month tapered off to once daily within 6 months and then once a day for 6 months.

Intervention: DMS 0.1% 6 times a day for 1 month followed by FML 0.1% 4 times a day for two months tapered off to once daily within four months and then once a day for 6 months.

STEP-II (Year 2):

Control: Half the patients in each study arm will use FML 0.1% daily.

Intervention: Half the patients in each study arm will discontinue steroids.

 

Outcomes

Primary outcomes:

Step-I: IOP elevation.

Step-II: Endothelial cell loss (ECL).

 

Secondary outcomes:

Rejection free graft survival.

Patient reported outcome measures.

Incremental cost-effectiveness ratios.

 

Sample size / data analysis

Step-I: Assuming IOP elevation incidence of 22% (control arm) and 6% (study arm), beta=0.8 and alpha=0.05, 342 patients are needed.

Step-II: We can detect a small minimal important clinical difference (Cohen’s d = 0.35) with beta=0.8 and alpha =0.05 , based on the calculated sample size.

 

Primary outcomes will be compared using logistic regression.

 

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